Brazil: ANVISA Issues Service Bulletin on Expedited Clinical Trial Review
July 12, 2021
The Brazil profile in ClinRegs has been updated to include Service Bulletin No. 104 - Document Analysis Procedures Required for DDCM Petitions and for Protocol Modifications that Potentially Impact Experimental Drug, Active Comparator or Placebo Quality/Safety, which the National Health Surveillance Agency (ANVISA) issued on June 21, 2021.
This service bulletin replaces Service Bulletin No. 88 and adds the United Kingdom to its list of countries where if a clinical trial protocol has been approved, the Clinical Drug Development Dossier (DDCM) in Brazil may undergo a simplified technical review. (See Scope of Assessment, Submission Process, Submission Content, Manufacturing & Import, and IMP/IND Quality Requirements)